Phase 1
Completed N=24
A Study of a New LY900014 Formulation in Healthy Participants
Healthy
Source: ClinicalTrials.gov NCT02525744 ↗
Enrolled (actual)
24
Serious AEs
0.0%
Results posted
May 2020
Primary outcomePrimary: Pharmacokinetics (PK) : Insulin Lispro Area Under the Concentration Curve Zero to Infinity (AUC[0-∞]) ) — 901; 1890; 3970; 1790 picomol per hour per L (pmol.h/L)
Summary
This study evaluates a new formulation of LY900014, a drug that lowers blood sugar. It is administered by injection under the skin of the abdomen. The study will be conducted in healthy people to investigate how quickly and how much LY900014 is absorbed and the effect of different doses of LY900014 on blood sugar levels. Side effects and tolerability will be documented. The study will last for about 8 to 9 weeks for each participant, including screening and follow up. Screening is required within 28 days prior to entering the study.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pharmacokinetics (PK) : Insulin Lispro Area Under the Concentration Curve Zero to Infinity (AUC[0-∞]) ) |
901; 1890; 3970; 1790 | — |
| SECONDARY Total Amount of Glucose Infused (Gtot) Over the Duration of Clamp |
42900; 82200; 122000; 70700 | — |
Eligibility Criteria
Inclusion Criteria
- Overtly healthy male or a female (not pregnant and agreeable to take birth control measures until one month after study completion)
- Have a body mass index (BMI) of 18.5 to 30 kilogram per square meter (kg/m^2), inclusive, at screening
- Have normal blood pressure, pulse rate, electrocardiogram (ECG), blood and urine laboratory test results that are acceptable for the study
- Are nonsmokers, have not smoked for at least 2 months prior to entering the study, and agree not to smoke (cigars, cigarettes, or pipes) or use smokeless tobacco for the duration of the study
Exclusion Criteria
- Are currently participating in or completed a clinical trial within the last 30 days or any other type of medical research judged to be incompatible with this study
- Have previously participated or withdrawn from this study
- Have or used to have health problems or laboratory test results or ECG readings that, in the opinion of the doctor, could make it unsafe to participate, or could interfere with understanding the results of the study
Data sourced from ClinicalTrials.gov (NCT02525744). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.